ERCP in Idiopathic Recurrent Acute Pancreatitis

• ClinicalTrials.gov Identifier: NCT01583517
• Recruitment Status: Completed
• First Posted: April 24, 2012
• Last Update Posted: October 10, 2014
• Sponsor: Indiana University
• Information provided by (Responsible Party): Indiana University

Study Description

Brief Summary:

The therapeutic impact of ERCP with sphincterotomy in the management of patients with idiopathic recurrent acute pancreatitis (RAP) needs further study. The investigators conducted a single center, feasibility, randomized trial to determine 1) the role of pancreatic manometry in predicting future episodes of RAP and 2) differences in the efficacy of no, biliary (BES) or pancreatobiliary (dual) endoscopic sphincterotomy (DES).

Condition or disease	Intervention/treatment	Phase
Recurrent Acute Pancreatitis	Procedure: Biliary sphincterotomy; Procedure: Pancreatobiliary sphincterotomy; Procedure: Sham	Not Applicable

Detailed Description:

Patients with idiopathic RAP, defined as ≥2 unexplained (per the treating physician) episodes of acute pancreatitis (based on standard criteria) requiring hospitalization, will be prospectively enrolled. All patients will undergo ERCP with manometry, with stratified randomization based on the assessment of pancreatic basal sphincter pressure. If <40mmHg, the patient will be randomized to sham or biliary sphincterotomy (BES). If ≥40mmHg, the patient will be randomized to BES or pancreatobiliary ("dual") sphincterotomy (DES).

Patients and physicians will not be blinded to the assignment group. Patients will be followed for up to 10 years to determine 1) incidence of RAP requiring hospitalization (using standard definitions) or 2) interval development of chronic pancreatitis (CP).

Differences between patients who did and did not develop RAP during follow-up will be compared to evaluate for factors associated with AP during follow-up.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 89 participants
• Allocation: Randomized
• Intervention Model: Factorial Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Defining the Role of ERCP in the Evaluation and Treatment of Idiopathic Recurrent Acute Pancreatitis
• Study Start Date: September 1997
• Actual Primary Completion Date: April 2012
• Actual Study Completion Date: October 2014

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: Biliary sphincterotomy; Cutting of the biliary sphincter muscle alone	Procedure: Biliary sphincterotomy; Cutting of the biliary sphincter muscle.
Active Comparator: Dual sphincterotomy; Cutting of both the biliary and pancreatic sphincter muscles.	Procedure: Pancreatobiliary sphincterotomy; Cutting of both the biliary and pancreatic sphincter muscles.
Sham Comparator: Sham; Among patients with normal sphincter of Oddi manometry, patients will undergo no sphincterotomy (sham therapy).	Procedure: Sham; No sphincterotomy is performed in patients randomized to sham with normal SOM.
Active Comparator: Biliary sphincterotomy - Normal SOM; Among patients with normal SOM, patients may be randomized to empiric biliary sphincterotomy alone.	Procedure: Biliary sphincterotomy; Cutting of the biliary sphincter muscle.

Outcome Measures

Primary Outcome Measures :

1. Recurrent acute pancreatitis [ Time Frame: 120 months ]

   Patients will be followed post-ERCP for up to 10 years. The primary outcome is development of acute pancreatitis following the index ERCP, based on standard definitions.

   Acute pancreatitis is defined as new onset of pancreatic-type abdominal pain with associated elevation in serum amylase or lipase > 3 times the upper limit of normal, OR radiographic findings consistent with acute pancreatitis.

Secondary Outcome Measures :

1. Interval development of chronic pancreatitis [ Time Frame: 120 months ]
   Determine the incidence of chronic pancreatitis during prolonged follow-up. Chronic pancreatitis is defined as characteristic changes on cross sectional imaging (CT or MRI/MRCP) or ERP (Cambridge classification).
2. Secondary assessment of risk factors for developing recurrent acute pancreatitis during follow-up [ Time Frame: 120 months ]
   A post hoc analysis will be conducted to evaluate for independent factors associated with having recurrent acute pancreatitis during follow-up

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

• Idiopathic recurrent acute pancreatitis, defined as two or more episodes requiring hospitalization
• ERCP with SOM planned

Exclusion Criteria:

• Chronic pancreatitis
• Pancreas divisum
• Alternate etiology identified (e.g., CBD stone, IPMN)
• Inability to perform pancreatic manometry
• Pregnancy, age < 18, incarceration
• Inability to provide informed consent

Contacts and Locations

Locations

United States, Indiana

Indiana University Health University Hospital

Indianapolis, Indiana, United States, 46202

Sponsors and Collaborators

Indiana University

Investigators

• Principal Investigator: Stuart Sherman, MD; Indiana University

More Information

Publications of Results:

Coté GA, Imperiale TF, Schmidt SE, Fogel E, Lehman G, McHenry L, Watkins J, Sherman S. Similar efficacies of biliary, with or without pancreatic, sphincterotomy in treatment of idiopathic recurrent acute pancreatitis. Gastroenterology. 2012 Dec;143(6):1502-1509.e1. doi: 10.1053/j.gastro.2012.09.006. Epub 2012 Sep 11.

• Responsible Party: Indiana University
• ClinicalTrials.gov Identifier: NCT01583517 History of Changes
• Other Study ID Numbers: 1011003897
• First Posted: April 24, 2012
• Last Update Posted: October 10, 2014
• Last Verified: October 2014

Keywords provided by Indiana University:

Acute pancreatitis; ERCP; Sphincterotomy; Manometry; Sphincter of Oddi dysfunction

Additional relevant MeSH terms:

Pancreatitis; Pancreatic Diseases; Digestive System Diseases